Melphalan/HDS for Bile Duct Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Bile Duct Cancer+3 More
Melphalan/HDS - CombinationProduct
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare two groups of patients with intrahepatic cholangiocarcinoma, one of which will receive high-dose chemotherapy delivered specifically to the liver. The other group will continue with the standard cisplatin and gemcitabine treatment. The results will be measured in terms of overall survival.

Eligible Conditions
  • Bile Duct Cancer
  • Intrahepatic Cholangiocarcinoma
  • Bile Duct Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Bile Duct Cancer

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: ORR change will be assessed every 9 weeks through study completion, an average of 1 year

Year 1
Incidence of Treatment-Emergent Adverse Events (Safety)
Year 1
Progression-free survival, as determined by IRC
Year 2
Overall Survival
Week 9
Objective response rate as determined by IRC
Year 1
Objective response rate (CR + PR) as determined by the Investigator
Year 1
Progression-free survival, as determined by the Investigator
Week 6
Pharmacokinetic Outcome Measures: AUC
Pharmacokinetic Outcome Measures: CL
Pharmacokinetic Outcome Measures: Cmax
Pharmacokinetic Outcome Measures: Tmax
Year 1
Quality of Life (QOL) as measured by the functional health survey EQ-5D module

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Bile Duct Cancer

Trial Design

2 Treatment Groups

Cisplatin and Gemcitabine
1 of 2
Melphalan/PHP
1 of 2
Active Control
Experimental Treatment

295 Total Participants · 2 Treatment Groups

Primary Treatment: Melphalan/HDS · No Placebo Group · Phase 2 & 3

Melphalan/PHP
CombinationProduct
Experimental Group · 1 Intervention: Melphalan/HDS · Intervention Types: CombinationProduct
Cisplatin and Gemcitabine
Drug
ActiveComparator Group · 1 Intervention: Cisplatin and Gemcitabine · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: orr change will be assessed every 9 weeks through study completion, an average of 1 year

Who is running the clinical trial?

Delcath Systems Inc.Lead Sponsor
8 Previous Clinical Trials
468 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have intrahepatic cholangiocarcinoma diagnosed by histology.
You have a resectable ICC with less than 50% of the liver involved, and without clinically significant extra-hepatic disease (regional lymph node lesions [≤ 2 cm] are acceptable) based on CT.
You have at least one target lesion based on the evaluation criteria in solid tumors (RECIST 1.1).
You have an ECOG PS of 0-1.
You are male or female and aged ≥ 18 years.
Patients must weigh ≥ 35 kg (due to possible size limitations with respect to percutaneous catheterization of the femoral artery and vein using the Delcath Hepatic Delivery System).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 26th, 2021

Last Reviewed: October 29th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.